Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivikar Tab. 5/40 mg in Healthy Adult Male Subjects

A Randomized, Open-label, Single-Dose, 2-Treatment, 2-Way, 2-Period Crossover Study to Assess the Safety and the Pharmacokinetic Characteristics of Lodivikar Tab. 5/40 mg in Healthy Adult Male Subjects

The purpose of this study is to assess the pharmacokinetic characteristics of olmesartan and S-amlodipine after single oral administration of Sevikar tab. 10/40mg, a combination formulation of olmesartan and amlodipine as reference drug and Lodivikar tab. 5/40mg, a combination formulation of olmesartan and S-amlodipine as test drug in healthy male adults. Additionally the safety and tolerability of two drugs will be evaluated.

Study Overview

• Status: Completed
• Conditions: Healthy Male Subjects
• Intervention / Treatment: Drug: Sevikar tab. 10/40mg; Drug: Lodivikar tab. 5/40mg

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Kyung Gi
    • Anyang, Kyung Gi, Korea, Republic of, 430-720
      • Metrohospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male in the age of 20-45
• Body weight ≥ 55kg, IBW ± 20%
• Subject who sign on an informed consent form willingly

Exclusion Criteria:

• Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
• Subject with known for hypersensitivity reaction to S-amlodipine, amlodipine and olmesartan and dihydropyridine derivatives
• Clinically significant hypotension (SBP≤100mmHg, DBP≤60mmHg) or hypertension(SBP≥150mmHg, DBP≥95mmHg) when screening period
• Subject with known for history of disease or gastric surgery which affect on the absorption,

• Subject with any of the following conditions in laboratory test

  • AST or ALT > UNL (upper normal limit) x 1.5
  • Total bilirubin > UNL x 1.5
  • Renal failure with CLcr < 50mL/min calculated on Cockcroft-Gault [Cockcroft-Gault GFR = (140-age) * (Wt in kg) / (72 *Cr)]
  • Serum potassium < 3.5 mEq/L or > 5.5 mEq/L
• Continued excessive use of caffeine (caffeine >five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker(cigarette >10 cigarettes per day)
• Participation in any clinical investigation within 60days prior to study medication dosing
• Subject with whole blood donation within 60days, component blood donation within 30days prior to study medication dosing
• Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing
• Use of any prescription medication including oriental medication within 14 days prior to study medication dosing or over-the-counter medication within 7 days prior to study medication dosing
• Subject with mental illness or drug addiction
• Subject taking foods which affect on the absorption, distribution, metabolism or excretion of drug within 7days prior to study medication dosing
• Subject with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: R-T; First period: administration of reference drug, Second period: administration of test drug	Drug: Sevikar tab. 10/40mg; Reference drug: Sevikar tab. 10/40mg, 1T, single oral administration in the fasted state; Drug: Lodivikar tab. 5/40mg; Test drug: Lodivikar tab 5/40mg, 1T, single oral administration in the fasted state
Experimental: T-R; First period: administration of test drug, Second period: administration of reference drug	Drug: Sevikar tab. 10/40mg; Reference drug: Sevikar tab. 10/40mg, 1T, single oral administration in the fasted state; Drug: Lodivikar tab. 5/40mg; Test drug: Lodivikar tab 5/40mg, 1T, single oral administration in the fasted state

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration versus time curve (AUC)	0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144hr(19 points)
Peak Plasma Concentration (Cmax)	0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144hr(19 points)

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events	From study medication dosing day to follow-up period for maximum 7 days from the second period discharge

Collaborators and Investigators

• Sponsor: Hanlim Pharm. Co., Ltd.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: November 1, 2016
• First Submitted That Met QC Criteria: November 2, 2016
• First Posted (Estimate): November 4, 2016

Study Record Updates

• Last Update Posted (Estimate): November 4, 2016
• Last Update Submitted That Met QC Criteria: November 2, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: HL-LVK-101